FDA unveils plan for real-time review of clinical trial data, with AstraZeneca and Amgen already on board
The FDA announced a new initiative to allow real-time review of clinical trial data, with AstraZeneca and Amgen participating in a pilot program. The effort aims to reduce the lengthy drug development timeline, which typically takes 10 to 12 years.
The FDA has introduced a new initiative to enable real-time review of clinical trial data. AstraZeneca and Amgen are participating in a pilot program, with AstraZeneca's phase 2 Traverse trial and Amgen's phase 1b trial in small cell lung cancer reporting safety and efficacy signals to the FDA as they occur. The FDA's goal is to reduce the 10 to 12 year drug development timeline, with 45% of clinical development time currently spent on paperwork. A pilot program launching this summer will explore using AI to optimize early trials. The FDA will receive and validate data through software company Paradigm Health's platform. The real-time review is not meant to replace formal meetings between sponsors and the agency, and reviewers will decide how to use the information.
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